Skip to content

N/A 5011-1

by Salter Labs, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00607411007972 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Respiratory apnoea monitoring system
Model / Ref / Catalog
5011-1
Primary DI / UDI-DI
00607411007972
510(k) Number
FDA Product Code
BZQ
GMDN Term
Respiratory apnoea monitoring system
Device Class
Class II
Regulation Number
868.2375
GUDID distribution status
In Commercial Distribution

Related devices

Category: Respiratory apnoea monitoring system

Cleared under the same submission (K151874)

Show all (12)

Similar devices

Also classified as Respiratory apnoea monitoring system.

Other devices from Salter Labs, LLC

See all devices from Salter Labs, LLC →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No